MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 25CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLX125C
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pancreas procedure the jaws broke apart.The customer claimed they haven't stuffed to much tissue in the jaws or leveraged to heavy.It was replaced by another instrument.The procedure was delayed 5 minutes but was completed successfully.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/19/2025.D4 batch #: unknown.Additional information was requested and the following was obtained: did the electrode ceramic separate or break off? the electrode separated.Did the knife get damaged or break off? no.Is the jaw damaged but not broken off? the jaw was damaged but did not broke off.Is the jaw loose but not detached? loose.Is the top jaw broken off the of the device? yes.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/7/2026.Corrected data: h6 medical device problem code.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/28/2026.D4 batch #: a9875k.Investigation summary : the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the device was returned with the distal guide weld broken.No top jaw missing or electrode issues were noted.Upon visual inspection, of the device, it was observed that the ground and active rod wires were broken at the distal guide area.The device was tested on the generator, this resulted in the ¿close jaws on tissue and reactivate¿ alert screen, which is advising the generator cannot deliver energy.Then the "replace instrument" screen would be displayed after receiving the "close jaws on tissue and reactivate" message three times.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.Please refer to the ifu for proper handling of the device, note that ¿caution: do not grasp tissue beyond the electrode surface, in the hinge of the jaws.Do not overfill the jaws of the instrument with tissue.This could result in difficulty opening the jaws, partially cutting tissue, and unintended injury.

• Brand Name: ENSEAL X1 CURVED 25CM SHAFT
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (CINCINNATI)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 23850577
• Report Number: 3005075853-2025-09678
• Device Sequence Number: 15834363
• Product Code: GEI
• UDI-Device Identifier: 10705036015444
• UDI-Public: (01)10705036015444(17)300531(10)A9875K
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NSLX125C
• Device Lot Number: A9875K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 01/05/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown